New Magnesium Sulphate Protocol for Pre-eclampsia

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01846156
• Collaborator: (none)
• Enrollment: 240
• Location: 1
• Arms: 3
• Duration (Months): 11
• Patients Per Site Per Month: 21.8

Study Details

Study Description

Brief Summary

there is a standard magnesium sulphate protocol and newer protocols for pre-eclampsia, we need to make a trial to find the best protocol

Condition or Disease	Intervention/Treatment	Phase
Pre-eclampsia	Drug: MgSO4	Phase 3

Detailed Description

The aim of our study is to assess the comparative effects of three regimens for the administration of magnesium sulfate when used for the care of women with severe pre-eclampsia.

The study will include 240 pregnant women presenting to the casualty unit with criteria of severe preeclampsia in the form of one of the criteria:-

• Systolic blood pressure ≥ 160.

• Diastolic blood pressure ≥ 110.

• Proteinuria > +2 by dip stick.

• Presence of alarming symptoms (headache, visual disturbance, epigastric pain, vaginal bleeding).

• Fetal growth restriction (IUGR).

After obtaining an informed consent the patients will be subjected to the following:

• Careful history taking including age, parity, gestational age.

• Complete physical examination and assessment of the blood pressure.

• Urine analysis by dipstick.

• All women will take initial MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes by IV drip) .

Using Random Number Table, the sample size will be divided into three categories:-

• Category A : 80 patients given full dose of maintenance MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip for 24 hours) in the postpartum period.

• Category B : 80 patients given abbreviated doses of MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip only for 12 hours) in the postpartum period.

• Category C : 80 patients who will take only loading dose of MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes) with no postpartum maintenance sulfate.

Inclusion criteria:

• Pregnant females ≥20 weeks of gestation.

• Pregnant females with criteria of severe pre-eclampsia.

• Single or multi-fetal pregnancy.

• Primigravida or Multigravida.

Exclusion criteria:

• Pregnant females < 20 weeks gestation.

• Pregnant females with history of epilepsy.

• Pregnant females with diabetes.

• Pregnant females with chronic hypertension.

• Pregnant females with renal disease.

Study Design

• Study Type: Interventional
• Actual Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Best Magnesium Sulphate Protocol for Severe Pre-eclampsia : A Randomized Controlled Trial
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Abrreviated MgSO4 protocol - Category B : 80 patients given abbreviated doses of MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip only for 12 hours) in the postpartum period.	Drug: MgSO4; A randomized controlled study that compare three regimens for administration of MgSO4 used for the cases of severe pre-eclampsia that will be performed in the Obstetrics & Gynecology Department, Kasr Al-Ainy Hospital, Cairo University
Experimental: No maintenance protocol - Category C : 80 patients who will take only loading dose of MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes) with no postpartum maintenance sulfate	Drug: MgSO4; A randomized controlled study that compare three regimens for administration of MgSO4 used for the cases of severe pre-eclampsia that will be performed in the Obstetrics & Gynecology Department, Kasr Al-Ainy Hospital, Cairo University
Active Comparator: standard MgSO4 protocol - Category A : 80 patients given full dose of maintenance MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip for 24 hours) in the postpartum period.	Drug: MgSO4; A randomized controlled study that compare three regimens for administration of MgSO4 used for the cases of severe pre-eclampsia that will be performed in the Obstetrics & Gynecology Department, Kasr Al-Ainy Hospital, Cairo University

Outcome Measures

Primary Outcome Measures

1. duration of MgSo4 treatment [1 year]

   treatment duration

Secondary Outcome Measures

1. ICU admission [1 year]

   ICU admission

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 42 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Pregnant females ≥20 weeks of gestation.

• Pregnant females with criteria of severe pre-eclampsia.

• Single or multi-fetal pregnancy.

• Primigravida or Multigravida.

Exclusion Criteria:

• Pregnant females < 20 weeks gestation.

• Pregnant females with history of epilepsy.

• Pregnant females with diabetes.

• Pregnant females with chronic hypertension.

• Pregnant females with renal disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr Alainy hospital	Cairo		Egypt	12311

Sponsors and Collaborators

• Cairo University

Investigators

• Principal Investigator: Waleed El-khayat, M.D., Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Waleed El-khayat, Assistant Professor of Obstetrics & Gynecology, Cairo University
• ClinicalTrials.gov Identifier: NCT01846156
• Other Study ID Numbers: 52103; 52013
• First Posted: May 3, 2013
• Last Update Posted: Aug 22, 2014
• Last Verified: Aug 1, 2014

• Keywords provided by Waleed El-khayat, Assistant Professor of Obstetrics & Gynecology, Cairo University: convulsion rate
• Additional relevant MeSH terms: Eclampsia; Pre-Eclampsia

Study Results

No Results Posted as of Aug 22, 2014